Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplant Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma

NCT00016887 | Unknown Phase 3

• 5 other identifiers: CDR0000068609GER-LGLSG-INTERGROUP-20995EORTC-20995GELA-INTERGROUP-20995GISL-INTERGROUP-20995
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether giving more than one drug (combination chemotherapy) with radiation therapy and peripheral stem cell transplant is more effective than chemotherapy followed by interferon alfa in treating mantle cell lymphoma. PURPOSE: This randomized phase III trial compares how well chemotherapy followed by radiation therapy, chemotherapy, and peripheral stem cell transplant works compared to chemotherapy plus interferon alfa in treating patients who have stage III or stage IV mantle cell lymphoma.

Conditions

Lymphoma

Keywords

stage III mantle cell lymphoma; stage IV mantle cell lymphoma

Interventions

filgrastim BIOLOGICAL

recombinant interferon alfa BIOLOGICAL

carmustine DRUG

cyclophosphamide DRUG

cytarabine DRUG

dexamethasone DRUG

etoposide DRUG

melphalan DRUG

bone marrow ablation with stem cell support PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed stage III or IV mantle cell lymphoma * Previously untreated * Not qualified for primary potentially curative radiotherapy PATIENT CHARACTERISTICS: Age: * 18 to 65 years Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No impairment of liver function (unless due to lymphoma) * Transaminases no greater than 3 times normal * Bilirubin no greater than 2.0 mg/dL Renal: * No renal insufficiency * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No manifest heart failure or coronary heart disease * No severe uncontrolled hypertension Pulmonary: * No chronic lung disease with hypoxemia Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No severe uncontrolled diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior interferon * No prior organ, bone marrow, or peripheral blood stem cell transplantation Chemotherapy: * No prior cytostatic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• German Low Grade Lymphoma Study Group: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• Gruppo Italiano Studio Linfomi: collaborator
• Lymphoma Study Association: collaborator

Study Sites (2)

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Ospedale Civile Alessandria

Alessandria, I-15100, Italy

Location

Related Publications (1)

• Determann O, Hoster E, Ott G, Wolfram Bernd H, Loddenkemper C, Leo Hansmann M, Barth TE, Unterhalt M, Hiddemann W, Dreyling M, Klapper W; European Mantle Cell Lymphoma Network and the German Low Grade Lymphoma Study Group. Ki-67 predicts outcome in advanced-stage mantle cell lymphoma patients treated with anti-CD20 immunochemotherapy: results from randomized trials of the European MCL Network and the German Low Grade Lymphoma Study Group. Blood. 2008 Feb 15;111(4):2385-7. doi: 10.1182/blood-2007-10-117010. Epub 2007 Dec 12.

  PMID: 18077791 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Mantle-Cell

Interventions

Filgrastim; Interferon-alpha; Carmustine; Cyclophosphamide; Cytarabine; Dexamethasone; Etoposide; Melphalan; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Interferon Type I; Interferons; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucosides; Glycosides; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Wolfgang Hiddemann, MD, PhD

  Klinikum der Universitaet Muenchen - Grosshadern Campus

  STUDY CHAIR

• J. C. Kluin-Nelemans, MD, PhD

  University Medical Center Groningen

  STUDY CHAIR

• Alessandro Levis, MD

  Ospedale Civile Alessandria

  STUDY CHAIR

• Achiel Van Hoof, MD

  AZ Sint-Jan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: December 1, 2000
• Last Updated: September 17, 2013

Record last verified: 2003-08

Locations

BE (1); IT (1)